MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-08 for TRIVEX SYSTEM RESECTOR HANDPIECE 7210387 manufactured by Lemaitre Vascular, Inc..
[139344527]
We have received the device for evaluation. The handpiece was returned to us with the drive shaft disassembled from the motor unit. The end bell that secures the seal housing to the core tube was also missing. The pcb wires to the end bell were cut and the drive shaft pin and retainer cup were also missing along with seal housings' internal components and bearings. Based on the condition this device was received, the surgeon would not be able to use this device for the phlebectomy procedure. Based on the limited available information we have at this time, we are reporting this incident as we do not have adequate information about how this device was handled after the event at the user facility. The issue was detected during pre-use check and the device was not used in the patient.
Patient Sequence No: 1, Text Type: N, H10
[139344528]
During pre-use check, the blades of the resector did not spin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2019-00022 |
| MDR Report Key | 8405620 |
| Date Received | 2019-03-08 |
| Date of Report | 2019-03-08 |
| Date of Event | 2019-02-09 |
| Date Mfgr Received | 2019-02-08 |
| Device Manufacturer Date | 2017-12-29 |
| Date Added to Maude | 2019-03-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PRAGYA THIKEY |
| Manufacturer Street | 63 SECOND AVE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| Manufacturer Phone | 7812212266 |
| Manufacturer G1 | LEMAITRE VASCULAR, INC. |
| Manufacturer Street | 63 SECOND AVE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01803 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TRIVEX SYSTEM RESECTOR HANDPIECE |
| Generic Name | HANDPIECE |
| Product Code | DWQ |
| Date Received | 2019-03-08 |
| Returned To Mfg | 2019-03-06 |
| Catalog Number | 7210387 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEMAITRE VASCULAR, INC. |
| Manufacturer Address | 63 SECOND AVE BURLINGTON MA 02148 US 02148 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-08 |